Telisotuzumab Vedotin History and Updates

25 events · 2014 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

1
FDA Approvals
0
Label Revisions
24
Trial Milestones
0
Pivotal Publications
Telisotuzumab Vedotin — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2014201520162017201820192020202120222023202420252026202720282029Trial: NCT07323641 2026-02-19 → 2027-02-01 (primary completion)Trial: NCT06568939 2025-01-20 → 2028-02-29 (primary completion)Trial: NCT06093503 2024-05-31 → 2028-04-11 (primary completion)Trial: NCT05513703 2022-11-21 → 2024-10-28 (primary completion)Trial: NCT04928846 2022-03-25 → 2028-12-31 (primary completion)Trial: NCT03539536 2018-10-10 → 2026-07-31 (primary completion)Trial: NCT02099058 2014-01-15 → 2026-08-31 (primary completion)FDA approval — 2025-05-14 FDA approved Emrelis (telisotuzumab vedotin) (BLA 761384) Sponsor: ABBVIE INC. Class: Type 1 - New Molecular Entity.Results posted — 2025-10-24 Trial results posted: NCT05513703 A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Sqtoday (2026-07-17)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-17Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Telisotuzumab Vedotin since 2014, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (2)

2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT03539536
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT02099058
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07323641
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06568939
A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04928846
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participan
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06093503
Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04928846
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participan

Past events

2026
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07323641
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
2025
Results posted· ClinicalTrials.gov
Trial results posted: NCT05513703
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Sq
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06568939
A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy
2024
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05513703
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Sq
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06093503
Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity
2023
2022
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05513703
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Sq
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04928846
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participan
2021
2018
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT03539536
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
2014
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT02099058
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.